Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.


October 3, 1975

CASPAR W. WEINBERGER, Secretary of Health, Education and Welfare, ALEXANDER M. SCHMIDT, M.D., Commissioner of the Food and Drug Administration, CLIFFORD G. SHANE, Regional Director of the Food and Drug Administration, TERRY MUSSON, ALLEN R. HALPER, JOHN E. KLEMMER and THOMAS D. GARDINE, Employees of the Food and Drug Administration, Defendants

The opinion of the court was delivered by: NEAHER


 NEAHER, District Judge.

 Plaintiff Elizabeth Daley, a licensed physician practicing in New York City, brought this action under 28 U.S.C. §§ 1331 and 1337 seeking declaratory and injunctive relief aimed at preventing defendants (hereinafter "FDA") from any further attempts to conduct an inspection of her office. The case is now before the court on FDA's motion to dismiss the complaint or in the alternative for summary judgment. Rules 12(b)(6) and 56, F.R.Civ.P.

 In the course of plaintiff's practice it appears that she prescribes various drugs, including prednisone, testosterone, estradiol and combinations thereof, for patients suffering from rheumatic diseases, principally rheumatoid arthritis. She alleges that on or about February 10, 1975, defendant Allen R. Halper, an FDA investigator, visited her office in New York City, interrogated a registered nurse in her employ and served a Notice of Inspection pursuant to Section 704(a) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 374(a) ("the Act"). *fn1" On or about February 27, 1975, two other FDA investigators, defendants John E. Klemmer and Thomas D. Gardine, appeared at plaintiff's office, interrogated the registered nurse and served a second Notice of Inspection.

 Plaintiff believes that she is being investigated concerning a drug called Liefcort. Although she claims that FDA lacks jurisdiction under the Act *fn2" to investigate or inspect either her practice or the treatment she prescribes for her patients, she asserts her willingness to discuss with FDA officials, through her attorney, details of medications which she prepares, prescribes and administers to her patients.

 FDA acknowledges that its desire to inspect plaintiff's premises stems from a belief that in the course of plaintiff's practice she may be distributing Liefcort, a drug not approved by FDA. Liefcort, which is apparently used outside this country in the treatment of arthritis, is believed to consist of prednisone, testosterone and estradiol, in proportions known only to its discoverer, the late Dr. Robert Liefmann. FDA believes that some of it may have been shipped into the country and found its way into plaintiff's offices.

 Essentially four grounds are relied on in support of FDA's motion to dismiss or for summary judgment: (1) there is no justiciable controversy before the court; (2) FDA, an agency of the United States, has not consented to the suit and therefore it is barred by the doctrine of sovereign immunity; (3) there is an adequate remedy at law; and (4) FDA does have the statutory authority to investigate plaintiff's offices.

 The absence of a justiciable controversy is premised on a lack of ripeness, a question necessarily involving a discretionary determination as to whether a particular controversy is appropriate for judicial resolution. In situations, such as this, where a pre-enforcement attack is made on the validity of administrative action, the Court, in the drug trilogy cases Abbott Laboratories v. Gardner, 387 U.S. 136, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967); Toilet Goods Ass'n. v. Gardner, 387 U.S. 158, 18 L. Ed. 2d 697, 87 S. Ct. 1520 (1967); Gardner v. Toilet Goods Ass'n., 387 U.S. 167, 18 L. Ed. 2d 704, 87 S. Ct. 1526 (1967), has established guidelines for ascertaining the appropriateness of judicial intervention.

 The test to be applied is twofold in nature and involves an evaluation of "both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Abbott, supra, 387 U.S. at 149. The first part of the test, i.e., the fitness of the issues for resolution, itself consists of two parts -- whether the issues raised were purely legal in nature and whether the challenged agency action was final. Id.

 In Abbott, supra, the plaintiffs had challenged the authority of the Secretary of Health, Education and Welfare to promulgate certain regulations, which had already been the subject of hearings and had been published in final form with immediate compliance expected. Applying the two-part test, the Court noted that the tendered issues were purely legal and the agency action was in every respect final, not tentative, and not the action of a subordinate official. Abbott Laboratories, supra, 387 U.S. at 151. Additionally, the challenged regulations would have "a direct effect on the day-to-day business of all prescription drug companies . . ." (387 U.S. at 152), and therefore withholding judicial consideration would necessitate considerable hardship. Under those circumstances, the Court departed from the otherwise settled rule that courts are to avoid "entangling themselves in abstract disagreements over administrative policies" and that administrative agencies are entitled to be free "from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties." Abbott Laboratories, supra, 387 U.S. at 148-49.

 In this case, the only action taken by FDA has been to cause two notices of inspection to be served and to question plaintiff's nurse. The notices merely recite various statutory provisions authorizing FDA inspections without specifying the purpose of the inspection or what FDA expects to find on the premises it seeks to enter. *fn3"

 Applying the Abbott Laboratories test to these facts, the court is of opinion that discretion should not be exercised in favor of retaining jurisdiction. While the issue raised appears to be a purely legal one, i.e., the FDA's statutory authority to inspect a physician's office, there is here no final agency action whose legality the court may pass upon. Although FDA agents made two visits to plaintiff's office, no inspection was in fact conducted. The court is reluctant to anticipate what future action, if any, FDA may decide to take.

 In American Dietaids Co., Inc. v. Celebrezze, 317 F.2d 658 (2 Cir. 1963), the court affirmed the dismissal of an action brought to enjoin FDA inspectors from using concealed tape recorders during future inspections of a plaintiff's premises, saying:

"There is no ground in such a single past incident for declaratory relief against possible future inspections. There is no actual controversy now existing on which to found declaratory relief. . . . 'Especially where governmental action is involved, courts should not intervene unless the need for equitable relief is clear, not remote or speculative.' [Quoting from Eccles v. Peoples Bank ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.